Chronic disease management conventionally involves routinely monitoring patients who suffer from chronic disease to identify disease-related health problems before they become medically severe. Routine monitoring is also required in patients undergoing various forms of rehabilitation or primary prevention such as programs designed to promote healthy diet and exercise behavior. Disease management and prevention may also involve monitoring exercise and diet patterns of patients, as well as adherence to and adjustments of prescribed medicine. The management of chronic disease also often involves continuous treatment of a disease process with one or more medicines. Many of these medications have a relatively narrow therapeutic window; that is, there is a narrow range of medication dosages that provide optimal therapeutic effect without producing undesirable and potentially dangerous side effects. Other, often behavioral, factors such as illness, or changes in sleep, vitamins, diet, exercise, stress, menstrual cycles, etc. can impact the efficacy, absorption, dissipation, bioavailability and hence optimal dosing requirements of medication. Additionally, due to comorbid or co-occurring diseases or intercurrent illness, there are risks related to potential medication interactions that can also affect the efficacy dosing requirements of one or more of the medications used in treatment. Ideally, the effects of medication should be continuously monitored in order to insure that the patient is deriving maximal therapeutic benefit without suffering the effects of overmedication or from potentially dangerous interactions.
Most patient assessment of the efficacy of self-administered treatment programs such as medication regimens, rehabilitative recovery or primary prevention occurs in the offices of healthcare professionals. Unfortunately this is both time-consuming and expensive, and can only partially deal with issues related to timeliness and compliance. To overcome the disadvantages of requiring patients to visit a physician's office for assessment of their disease or condition, various health care organizations have implemented programs where case managers (i.e., persons with some level of medical training) telephone patients periodically to obtain patient data and to coordinate care. Unfortunately, with often hundreds of patients per case manager, personal contact with individual patients on a daily or even regular basis may be difficult. In addition, personal contact with individual patients on a regular basis may be somewhat expensive. Accordingly, case managers using conventional management techniques may not be able to monitor, adjust or promote a patient's medication dosage or other treatment regimen as often as desirable or necessary.
Another approach used in chronic disease management involves automated voice messaging (AVM) services, wherein patients receive regular telephone calls providing various educational and motivational messages from case managers. Exemplary messages may include reminding a patient of a scheduled physician visit. Some AVM services involve one-way communication, wherein a recorded message is delivered to a patient, but no information is obtained from the patient. As a result, the medical condition of a patient may not be available unless the patient is examined in-person by a physician.
AVM services involving two-way communications may allow patients to respond to AVM telephone queries via a touch tone telephone. Information received from patients may be reviewed by a case manager (CM). The CM then may identify which patients require callbacks for gathering more detailed information, discussing problems, or providing further information. Unfortunately, AVM services involving two-way communications may require some level of human intervention to identify patients with medically severe conditions that require immediate medical attention, such as a change in warfarin or insulin dosage. Chronic disease management via AVM has another drawback in that delays may occur between the identification of a patient with a medically severe condition and actual treatment of the condition.
In order to assist the physician and CM in following a patient with chronic disease, home monitoring devices have been developed and marketed that can collect physiologic data and report this data back to the physician. Examples of such devices include home blood glucose monitors, home blood pressure monitors, home peek-flow monitors for asthma, and home coagulation time monitors for patients undergoing anticoagulation therapy. While these systems can collect physiologic data at home, they do not provide direct guidance to the patient on need changes in chronic medication dosing. They also do not provide a convenient way for physicians to use the data generated to cost-effectively manage patients.
In addition to case managers, AVMs, and home diagnostic devices, several systems have been devised that collect disease-related data at home and transmit them to a central location where the data can be analyzed by a physician or other healthcare professionals. Such systems include DIABCARE (Roche Diagnostics), THE BUDDY SYSTEM, HEALTH HERO, and LIFECHART. Some of these systems directly interface with home physiologic monitors (e.g., DIABCARE and LIFECHART) as described above. However, all of these systems simply collect data from remotely-located patients and present the data in summary form. They do not attempt to help the physician or health care provider prioritize patients in need of attention, recommend actions to ameliorate the patient's condition, or give information back to the patient about what he or she should do in the event the a change in the therapy regimen in indicated.
One system that has attempted to automate disease management for insulin therapy in diabetes mellitus is the DIACARE® System, described in U.S. Pat. No. 4,731,726. Unfortunately, the DIACARE® System is narrowly focused on treating diabetic patients using insulin, and lacks many of the important features of a system that would be necessary for delivering a wide variety of interventions in a number of medical diseases or conditions such as anticoagulation therapy.
Warfarin and other anticoagulant therapies are indicated for conditions involving the increased likelihood of fibrin clot (thrombosis). These thromboses may increase the likelihood of stroke, myocardial infarctions or other cardiovascular events. Anticoagulant therapies interfere with or decrease the ability of the body to form a fibrin clot (thrombosis). Since under-medication can result in a thrombosis, and overmedication can result in potentially disastrous hemorrhagic complications, all of these therapies need to be very closely monitored. Examples of these therapies and the types of tests used to monitor them are shown in Table 1 below:
TABLE 1Anticoagulation Therapies & TestsTHERAPYTESTWarfarin and other vitaminProthrombin (PT)K antagonistsHeparin and similarPartial ThromboplastinglucosaminoglycansTime (PTT)Activated Clotting Time(ACT)Specific heparin or lowlow molecular weightheparin assaysDirect thrombin inhibitorsEcarin clotting time (ECT)(e.g., hirutin,Thrombin clotting timemelagatgran)PT or PTT
PT or other coagulation tests (listed in Table 1) and regular visits to the physician or clinic are needed to monitor anticoagulation therapy. Anticoagulation therapy is a highly individualized matter that should be monitored closely. Numerous factors, alone or in combination, including travel, changes in diet, environment, physical state and medication may influence response of a patient to anticoagulants. As such, anticoagulant dosage should be controlled by periodic determinations of prothrombin time (PT)/International Normalized Ratio (INR) or other suitable coagulation tests.
Coagulation tests and regular visits to the physician or clinic are typically required to effectively monitor anticoagulation therapy. Unfortunately, regular visits to a physician or clinic can be expensive and inconvenient. In addition, patients may be required to attend training prior to being allowed to self-administer medication and testing regimens. Such training may be too complex and/or cost-prohibitive for many patients.